The U.S. Food and Drug Administration (FDA) has called out Philips Respironics for its inadequate efforts in notifying patients, suppliers, and healthcare providers of a massive recall of some of the company’s breathing assistance devices. On March 10, 2022, the agency ordered the company to notify these users of the recall and the products’ risks.
Attorney Buchanan said she looks forward to bringing justice to those who have suffered from the defective medical devices.
The company further informs that it has produced around 750,000 replacement devices and repair kits. More than 250,000 are actually in consumers’ hands.
The delay in receiving new devices has been a point of frustration for users.
As of September 28, 2021, a total of 93 class actions had been filed against Continuous Positive Air Pressure (CPAP) maker Philips Respironics. The Judicial Panel on Multidistrict Litigation announced it will hear motions to consolidate or coordinate pretrial proceedings for these lawsuits.
The U.S. Food and Drug Administration (FDA) issued notice that Philips Respironics recalled its V60 Plus Ventilators Equipped with High Flow Therapy (software version 3.00 and 3.10) and all V60 ventilators that have been upgraded to enable High Flow Therapy with this software. The manufacturer distributed the affected devices between May 1, 2009, and June 2, 2021.
Phillips Respironics has issued a voluntary recall of around 4 million CPAP and BiLevel PAP devices. According to the manufacturer’s notification, the company’s quality management system revealed these products pose serious health risks and potentially life-threatening injuries for users.
The first-generation DreamStation product family comprises the Philips medical devices most affected by the recall.